2019-28249. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [e-mail].

SUPPLEMENTARY INFORMATION:

The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at http://www.reginfo.gov/​public/​do/​PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Table 1—List of Information Collections Approved by OMB

Title of collection	OMB control No.	Date approval expires
Mammography Quality Standards Act Requirements	0910-0309	10/31/2022
Prescription Drug Product Labeling; Medication Guide Requirements	0910-0393	10/31/2022
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed	0910-0513	10/31/2022
Current Good Manufacturing Practice for Positron Emission	0910-0667	10/31/2022
Abbreviated New Animal Drug Applications	0910-0669	10/31/2022
Medical Devices: Use of Certain Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling	0910-0740	10/31/2022
Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act	0910-0768	10/31/2022
Investigational Device Exemptions Reports and Records	0910-0078	11/30/2022
510(k) Third-Party Review Program	0910-0375	11/30/2022
Guidance for Industry With the Center for Veterinary Medicine's Electronic Submission System	0910-0454	11/30/2022

Dated: December 16, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.